Recall Z-2269-2014— Gyrus Medical, Inc

Class II FDA medical device recall by Gyrus Medical, Inc, initiated 2014-07-08, terminated 2015-05-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists of a cylindrical radiopaque silicone band that occludes the lumen of the Fallopian tube when placed over a looped segment of the tube. The FRB-30 (used with the reusable applicators) consists of one reusable Falope-Ring Guide, an instruction manual and 30 procedure kits. Each kit is provided sterile and includes one dilator and two Falope Bands.. Reason: Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold as a stand-alone non-sterile component. The dilator is intended to assist placement of the Falope-Ring band on the reusable Falope applicator..

Recalling firm

Gyrus Medical, Inc

Classification

Class II

Status

Terminated

Initiated

2014-07-08

Terminated

2015-05-07

Firm location

Osseo, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.